Status:
ACTIVE_NOT_RECRUITING
Extended Release Naltrexone Versus Extended Release Buprenorphine with Individuals Leaving Jail
Lead Sponsor:
Friends Research Institute, Inc.
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender ...
Detailed Description
This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will participate in a r...
Eligibility Criteria
Inclusion
- Adult male or female inmates at participating jails who are eligible for release within 120 days
- History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration)
- Suitability for XR-B and/or XR-NTX treatment as determined by medical evaluation
- Willingness to enroll in XR-B or XR-NTX treatment in jail
- Planning to live in one of the 7 participating counties and/or surrounding counties
Exclusion
- Liver function test levels greater than 4 times normal;
- Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);
- Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant)
- Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed);
- History of allergic reaction to naltrexone and/or buprenorphine;
- Current chronic pain diagnosis for which opioids are prescribed;
- Pregnancy (for women);
- Breast-feeding (for women);
- Suicidal ideation (within the past 6 months);
- Body Mass Index (BMI) \> 40;
- Inability to pass a study enrollment quiz;
- Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine, naltrexone)
- Enrolled in a methadone treatment program in the past 30 days.
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04408313
Start Date
October 28 2020
End Date
December 31 2025
Last Update
March 7 2025
Active Locations (1)
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1
Friends Research Institute
Baltimore, Maryland, United States, 21201